Hearing LossNCT05870527
Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
A study testing Electrical stimulator in people with Hearing Loss, run by NYU Langone Health at 1 site in United States.
Trial summary
The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cochlear implantation:
- will be undergoing surgery for a cochlear implant
- is over the age of 18
- is willing to participate in the study
- Patients undergoing vagal nerve stimulator implantation:
- will be undergoing implantable vagal nerve stimulation
- is over the age of 18
- is willing to participate in the study
Who cannot join
- Patients undergoing cochlear implantation:
- is under the age of 18
- has history of prior ear surgery, congenital ear malformation, or cochlear implantation
- pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
- medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:
- One vagus nerve
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- Receiving other concurrent forms of brain stimulation
- Heart arrhythmias or other heart abnormalities
- Dysautonomias (abnormal functioning of the autonomic nervous system)
- Lung diseases or disorders (shortness of breath, asthma, etc.)
- Ulcers (gastric, duodenal, etc.)
- Vasovagal syncope (fainting)
- Pre-existing hoarseness
- Patients undergoing vagal nerve stimulator implantation:
- is under the age of 18
- has history of prior ear surgery, congenital ear malformation, or cochlear implantation
- pregnant or breastfeeding
- medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:
- One vagus nerve
- Receiving other concurrent forms of brain stimulation
- Heart arrhythmias or other heart abnormalities
- Dysautonomias (abnormal functioning of the autonomic nervous system)
- Lung diseases or disorders (shortness of breath, asthma, etc.)
- Ulcers (gastric, duodenal, etc.)
- Vasovagal syncope (fainting)
- Pre-existing hoarseness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.
Read the detailed description
The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation
- Conditions
- Hearing Loss
- Being tested
- Electrical stimulator
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulatorDevice
Electrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA.
| Study group | Role | What they receive |
|---|---|---|
| Vagal Nerve Stimulation during Cochlear Implantation Surgery | Experimental | Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation. Receives: Device: Electrical stimulator |
| Vagal Nerve Stimulator Implantation | No intervention | Control cohort undergoing vagal nerve stimulator implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary Dilation during Procedure
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.
Measured: Day 1 (During procedure - typically 1 hour in duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start10 Jul 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Thomas Roland Jr., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870527
- Sponsor's protocol ID
- 23-00248
- Status last verified
- Jan 2026
- First submitted
- 12 May 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: justin.cottrell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
- ClinicalTrials.gov ID
- NCT05870527
- Acronym / sponsor ID
- 23-00248
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.
Detailed description
The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagal Nerve Stimulation during Cochlear Implantation Surgery | Experimental | Device: Electrical stimulatorParticipants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation. |
| Vagal Nerve Stimulator Implantation | No intervention | –Control cohort undergoing vagal nerve stimulator implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- will be undergoing surgery for a cochlear implant
- is over the age of 18
- is willing to participate in the study
- will be undergoing implantable vagal nerve stimulation
- is over the age of 18
Key exclusion criteria (26 listed)
- is under the age of 18
- has history of prior ear surgery, congenital ear malformation, or cochlear implantation
- pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
- medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria for VNS and include the following:
- is under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulatorElectrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA. | Device | Vagal Nerve Stimulation during Cochlear Implantation Surgery |
Primary outcome
Pupillary Dilation during Procedure
Time frame: Day 1 (During procedure - typically 1 hour in duration)
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: justin.cottrell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Thomas Roland Jr. principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulator in people with Hearing Loss, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary Dilation during Procedure (time frame: Day 1 (During procedure - typically 1 hour in duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.